AN ACT
1-1 relating to the regulation of pharmacies and pharmacists; providing
1-2 a penalty.
1-3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-4 SECTION 1. Section 5, Texas Pharmacy Act (Article 4542a-1,
1-5 Vernon's Texas Civil Statutes), is amended to read as follows:
1-6 Sec. 5. DEFINITIONS. In this Act, unless the context of
1-7 its use clearly indicates otherwise:
1-8 (1) "A.C.P.E." means the American Council on
1-9 Pharmaceutical Education.
1-10 (2) "Administer" means the direct application of a
1-11 prescription drug by injection, inhalation, ingestion, or any other
1-12 means to the body of a patient by:
1-13 (A) a practitioner, an authorized agent under
1-14 his supervision, or other person authorized by law; or
1-15 (B) the patient at the direction of a
1-16 practitioner.
1-17 (3) "Administrative Procedure Act" means Chapter 2001,
1-18 Government Code [the Administrative Procedure and Texas Register
1-19 Act, as amended (Article 6252-13a, Vernon's Texas Civil Statutes)].
1-20 (4) "Board" means the Texas State Board of Pharmacy.
1-21 (5) "Class A pharmacy license" or "community pharmacy
1-22 license" means a license issued to a pharmacy dispensing drugs or
1-23 devices to the general public pursuant to a prescription drug
2-1 order.
2-2 (6) "Class B pharmacy license" or "nuclear pharmacy
2-3 license" means a license issued to a pharmacy dispensing or
2-4 providing radioactive drugs or devices for administration to an
2-5 ultimate user.
2-6 (7) "Class C pharmacy license" or "institutional
2-7 pharmacy license" means a license issued to a pharmacy located in a
2-8 hospital or other in-patient facility that is licensed under
2-9 Chapter 241, Health and Safety Code, or Chapter 6, Texas Mental
2-10 Health Code (Article 5547-1 et seq., Vernon's Texas Civil
2-11 Statutes), to a hospice in-patient facility that is licensed under
2-12 Chapter 142, Health and Safety Code, or to a pharmacy located in a
2-13 hospital maintained or operated by the state.
2-14 (8) "Class D pharmacy license" or "clinic pharmacy
2-15 license" means a license issued to a pharmacy dispensing a limited
2-16 type of drugs or devices pursuant to a prescription drug order.
2-17 (9) "Class E pharmacy license" or "nonresident
2-18 pharmacy license" means a license issued under this Act to a
2-19 pharmacy located in a state of the United States other than this
2-20 state whose primary business is to dispense a prescription drug or
2-21 device under a prescription drug order and to deliver the drug or
2-22 device to a patient, including a patient in this state, by the
2-23 United States mail, a common carrier, or a delivery service.
2-24 (10) [(11)] "College of pharmacy" means a school,
2-25 university, or college of pharmacy that satisfies the accreditation
3-1 standards of A.C.P.E. as adopted by the board; or that has degree
3-2 requirements which meet the standards of accreditation set by the
3-3 board.
3-4 (11) [(12)] "Compounding" means the preparation,
3-5 mixing, assembling, packaging, or labeling of a drug or device:
3-6 (A) as the result of a practitioner's
3-7 prescription drug order or initiative based on the
3-8 practitioner-patient-pharmacist relationship in the course of
3-9 professional practice;
3-10 (B) in anticipation of prescription drug orders
3-11 based on routine, regularly observed prescribing patterns; or
3-12 (C) for the purpose of or as an incident to
3-13 research, teaching, or chemical analysis and not for sale or
3-14 dispensing.
3-15 (12) [(13)] "Confidential record" means any
3-16 health-related record that contains information that identifies an
3-17 individual and that is maintained by a pharmacy or pharmacist such
3-18 as a patient medication record, prescription drug order, or
3-19 medication order.
3-20 (13) [(14)] "Controlled substance" means a drug,
3-21 immediate precursor, or other substance listed in Schedules I-V or
3-22 Penalty Groups 1-4 of Chapter 481, Health and Safety Code, or a
3-23 drug, immediate precursor, or other substance included in Schedule
3-24 I, II, III, IV, or V of the Federal Comprehensive Drug Abuse
3-25 Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
4-1 (14) [(15)] "Controlled Substances Act" means Chapter
4-2 481, Health and Safety Code, or the Federal Comprehensive Drug
4-3 Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et
4-4 seq.).
4-5 (15) [(16)] "Dangerous drug" means any drug or device
4-6 that is not included in Penalty Groups 1-4 of the Controlled
4-7 Substances Act and that is unsafe for self-medication or any drug
4-8 or device that bears or is required to bear the legend:
4-9 (A) "Caution: federal law prohibits dispensing
4-10 without prescription"; or
4-11 (B) "Caution: federal law restricts this drug
4-12 to use by or on the order of a licensed veterinarian."
4-13 (16) [(17)] "Dangerous Drug Act" means Chapter 483,
4-14 Health and Safety Code.
4-15 (17) [(18)] "Deliver" or "delivery" means the actual,
4-16 constructive, or attempted transfer of a prescription drug or
4-17 device or controlled substance from one person to another, whether
4-18 or not for a consideration.
4-19 (18) [(19)] "Designated agent" means:
4-20 (A) a licensed nurse, physician assistant,
4-21 pharmacist, or other individual designated by a practitioner, and
4-22 for whom the practitioner assumes legal responsibility, who
4-23 communicates prescription drug orders to a pharmacist;
4-24 (B) a licensed nurse, physician assistant, or
4-25 pharmacist employed in a health care facility to whom the
5-1 practitioner communicates a prescription drug order; or
5-2 (C) a registered nurse or physician assistant
5-3 authorized by a practitioner to carry out a prescription drug order
5-4 for dangerous drugs under Subdivision (5) or (6), Subsection (d),
5-5 Section 3.06, Medical Practice Act (Article 4495b, Vernon's Texas
5-6 Civil Statutes).
5-7 (19) [(20)] "Device" means an instrument, apparatus,
5-8 implement, machine, contrivance, implant, in vitro reagent, or
5-9 other similar or related article, including any component part or
5-10 accessory, that is required under federal or state law to be
5-11 ordered or prescribed by a practitioner.
5-12 (20) [(21)] "Dispense" means preparing, packaging,
5-13 compounding, or labeling for delivery a prescription drug or device
5-14 in the course of professional practice to an ultimate user or his
5-15 agent by or pursuant to the lawful order of a practitioner.
5-16 (21) [(22)] "Distribute" means the delivery of a
5-17 prescription drug or device other than by administering or
5-18 dispensing.
5-19 (22) [(23)] "Drug" means:
5-20 (A) a substance recognized as drugs in the
5-21 current official United States Pharmacopoeia, official National
5-22 Formulary, official Homeopathic Pharmacopoeia, or other drug
5-23 compendium or any supplement to any of them;
5-24 (B) a substance intended for use in the
5-25 diagnosis, cure, mitigation, treatment, or prevention of disease in
6-1 man or other animals;
6-2 (C) a substance, other than food, intended to
6-3 affect the structure or any function of the body of man or other
6-4 animals;
6-5 (D) a substance intended for use as a component
6-6 of any articles specified in Paragraph (A), (B), or (C) of this
6-7 subdivision;
6-8 (E) a dangerous drug; or
6-9 (F) a controlled substance.
6-10 (23) [(24)] "Drug regimen review" includes the
6-11 following activities:
6-12 (A) evaluation of prescription drug or
6-13 medication orders and patient medication records for:
6-14 (i) known allergies;
6-15 (ii) rational therapy-contraindications;
6-16 (iii) reasonable dose and route of
6-17 administration; and
6-18 (iv) reasonable directions for use;
6-19 (B) evaluation of prescription drug or
6-20 medication orders and patient medication records for duplication of
6-21 therapy;
6-22 (C) evaluation of prescription drug or
6-23 medication orders and patient medication records for:
6-24 (i) drug-drug interactions;
6-25 (ii) drug-food interactions;
7-1 (iii) drug-disease interactions;
7-2 (iv) adverse drug reactions; and
7-3 (D) evaluation of prescription drug and
7-4 medication orders and patient medication records for proper
7-5 utilization, including overutilization or underutilization.
7-6 (24) [(25)] "Internship" means a practical experience
7-7 program that is approved by the board.
7-8 (25) [(26)] "Label" means written, printed, or graphic
7-9 matter on the immediate container of a drug or device.
7-10 (26) [(27)] "Labeling" means the process of affixing a
7-11 label including all information required by federal and state law
7-12 or regulation to any drug or device container. The term does not
7-13 include the labeling by a manufacturer, packer, or distributor of a
7-14 nonprescription drug or commercially packaged prescription drug or
7-15 device, or unit dose packaging.
7-16 (27) [(28)] "Manufacturing" means the production,
7-17 preparation, propagation, conversion, or processing of a drug or
7-18 device, either directly or indirectly, by extraction from
7-19 substances of natural origin or independently by means of chemical
7-20 or biological synthesis and includes any packaging or repackaging
7-21 of the substances or labeling or relabeling of the container and
7-22 the promotion and marketing of such drugs or devices.
7-23 Manufacturing also includes the preparation and promotion of
7-24 commercially available products from bulk compounds for resale by
7-25 pharmacies, practitioners, or other persons but does not include
8-1 compounding.
8-2 (28) [(29)] "Medication order" means an order from a
8-3 practitioner or a practitioner's designated agent for
8-4 administration of a drug or device.
8-5 (29) [(30)] "Nonprescription drug" means a nonnarcotic
8-6 drug or device that may be sold without a prescription and that is
8-7 labeled and packaged in compliance with applicable state or federal
8-8 law.
8-9 (30) [(31)] "Patient counseling" means the
8-10 communication by the pharmacist of information, as specified in the
8-11 rules of the board, to the patient or caregiver, in order to
8-12 improve therapy by ensuring proper use of drugs and devices.
8-13 (31) [(32)] "Person" means an individual, corporation,
8-14 government or governmental subdivision or agency, business trust,
8-15 estate, trust, partnership, association, or any other legal entity.
8-16 (32) [(33)] "Pharmaceutical care" is the provision of
8-17 drug therapy and other pharmaceutical services defined in the rules
8-18 of the board and intended to assist in the cure or prevention of a
8-19 disease, elimination or reduction of a patient's symptoms, or
8-20 arresting or slowing of a disease process.
8-21 (33) [(34)] "Pharmacist" means a person licensed by
8-22 the board to practice pharmacy.
8-23 (34) [(35)] "Pharmacist-in-charge" means the
8-24 pharmacist designated on a pharmacy license as the pharmacist who
8-25 has the authority or responsibility for a pharmacy's compliance
9-1 with laws and rules pertaining to the practice of pharmacy.
9-2 (35) [(36)] "Pharmacist-intern" means an undergraduate
9-3 student enrolled in the professional sequence of a college of
9-4 pharmacy approved by the board and participating in a school-based,
9-5 board-approved internship program or a graduate of a college of
9-6 pharmacy who is participating in a board-approved internship.
9-7 (36) [(37)] "Pharmacy" means a facility at which
9-8 prescription drug or medication orders are received, processed, or
9-9 dispensed under this Act, the Dangerous Drug Act, or the Controlled
9-10 Substances Act. The term does not include a narcotic drug
9-11 treatment program that is regulated by Chapter 466, Health and
9-12 Safety Code [licensed by the board pursuant to Section 29 of this
9-13 Act].
9-14 (37) "Pharmacy technician" means an individual
9-15 employed by a pharmacy whose responsibility is to provide technical
9-16 services that do not require professional judgment regarding the
9-17 preparation and distribution of drugs and who works under the
9-18 direct supervision of and is responsible to a pharmacist.
9-19 (38) "Practice of pharmacy" means:
9-20 (A) provision of those acts or services
9-21 necessary to provide pharmaceutical care;
9-22 (B) interpretation and evaluation of
9-23 prescription drug orders or medication orders;
9-24 (C) participation in drug and device selection
9-25 as authorized by law, drug administration, drug regimen review, or
10-1 drug or drug-related research;
10-2 (D) provision of patient counseling;
10-3 (E) responsibility for:
10-4 (i) dispensing of prescription drug orders
10-5 or distribution of medication orders;
10-6 (ii) compounding and labeling of drugs and
10-7 devices, except labeling by a manufacturer, repackager, or
10-8 distributor of nonprescription drugs and commercially packaged
10-9 prescription drugs and devices;
10-10 (iii) proper and safe storage of drugs and
10-11 devices; or
10-12 (iv) maintenance of proper records for
10-13 drugs and devices; or [and]
10-14 (F) performance of a specific act of drug
10-15 therapy management for a patient delegated to a pharmacist by a
10-16 written protocol from a physician licensed in this state in
10-17 compliance with the Medical Practice Act (Article 4495b, Vernon's
10-18 Texas Civil Statutes).
10-19 (39) "Practitioner" means:
10-20 (A) a physician, dentist, podiatrist,
10-21 veterinarian, or other person licensed or registered to prescribe,
10-22 distribute, administer, or dispense a prescription drug or device
10-23 in the course of professional practice in this state;
10-24 (B) a person licensed by another state in a
10-25 health field in which, under Texas law, licensees in this state may
11-1 legally prescribe dangerous drugs or a person practicing in another
11-2 state and licensed by another state as a physician, dentist,
11-3 veterinarian, or podiatrist, having a current Federal Drug
11-4 Enforcement Administration registration number, and who may legally
11-5 prescribe Schedule II, III, IV, or V controlled substances in such
11-6 other state; or
11-7 (C) a person licensed in the Dominion of Canada
11-8 or the United Mexican States in a health field in which, under the
11-9 laws of this state, a licensee may legally prescribe dangerous
11-10 drugs. "Practitioner" does not include a person licensed under
11-11 this Act.
11-12 (40) "Preceptor" means a pharmacist [in good standing]
11-13 licensed in this state to practice pharmacy who meets the preceptor
11-14 requirements specified by rule and who is certified by the board to
11-15 supervise and be responsible for the activities and functions of a
11-16 pharmacist-intern in the internship program.
11-17 (41) "Prescription drug" means:
11-18 (A) a substance for which federal or state law
11-19 requires a prescription before it may be legally dispensed to the
11-20 public;
11-21 (B) a drug or device that under federal law is
11-22 required, prior to being dispensed or delivered, to be labeled with
11-23 either of the following statements:
11-24 (i) "Caution: federal law prohibits
11-25 dispensing without prescription"; or
12-1 (ii) "Caution: federal law restricts this
12-2 drug to use by or on the order of a licensed veterinarian"; or
12-3 (C) a drug or device that is required by any
12-4 applicable federal or state law or regulation to be dispensed on
12-5 prescription only or is restricted to use by a practitioner only.
12-6 (42) "Prescription drug order" means:
12-7 (A) an order from a practitioner or a
12-8 practitioner's designated agent to a pharmacist for a drug or
12-9 device to be dispensed; or
12-10 (B) an order pursuant to Subdivision (5) or (6),
12-11 Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,
12-12 Vernon's Texas Civil Statutes).
12-13 (43) "Prospective drug use review" means a review of
12-14 the patient's drug therapy and prescription drug order or
12-15 medication order, as defined in the rules of the board, prior to
12-16 dispensing or distributing the drug.
12-17 (44) "Provide" means to supply one or more unit doses
12-18 of a nonprescription drug or dangerous drug to a patient.
12-19 (45) "Radioactive drug" means a drug that exhibits
12-20 spontaneous disintegration of unstable nuclei with the emission of
12-21 nuclear particles or photons, including any nonradioactive reagent
12-22 kit or nuclide generator that is intended to be used in the
12-23 preparation of any such substance.
12-24 (46) "Substitution" means the dispensing of a drug or
12-25 a brand of drug other than that which is ordered or prescribed.
13-1 (47) "Texas trade association" means a nonprofit,
13-2 cooperative association of business or professional competitors in
13-3 this state whose purpose is to assist its members, industry, or
13-4 profession and whose members have joined voluntarily. ["Supportive
13-5 personnel" means those individuals utilized in pharmacies whose
13-6 responsibility it shall be to provide technical services that do
13-7 not require professional judgment concerned with the preparation
13-8 and distribution of drugs under the direct supervision of and
13-9 responsible to a pharmacist.]
13-10 (48) "Ultimate user" means a person who has obtained
13-11 and possesses a prescription drug or device for the person's own
13-12 use or for the use of a member of the person's household or for
13-13 administering to an animal owned by the person or by a member of
13-14 the person's household.
13-15 (49) "Unit dose packaging" means the ordered amount of
13-16 drug in a dosage form ready for administration to a particular
13-17 patient, by the prescribed route at the prescribed time, and
13-18 properly labeled with name, strength, and expiration date of the
13-19 drug.
13-20 (50) "Written protocol" means a physician's order,
13-21 standing medical order, standing delegation order, or other order
13-22 or protocol as defined by rule of the Texas State Board of Medical
13-23 Examiners under the Medical Practice Act (Article 4495b, Vernon's
13-24 Texas Civil Statutes).
13-25 SECTION 2. Subsection (a), Section 8, Texas Pharmacy Act
14-1 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
14-2 read as follows:
14-3 (a) A licensed pharmacist member of the board:
14-4 (1) may not be:
14-5 (A) a salaried faculty member at a college of
14-6 pharmacy; or
14-7 (B) an officer, employee, or paid consultant of
14-8 a Texas trade association in the field of health care or a spouse
14-9 of an officer, employee, or paid consultant; and
14-10 (2) must at the time of his appointment:
14-11 (A) [(1)] be a resident of this state;
14-12 (B) [(2)] be licensed for the five years
14-13 immediately preceding appointment and be in good standing to engage
14-14 in the practice of pharmacy in this state; and
14-15 (C) [(3)] be engaged in the practice of pharmacy
14-16 in this state.
14-17 SECTION 3. Section 8, Texas Pharmacy Act (Article 4542a-1,
14-18 Vernon's Texas Civil Statutes), is amended by adding Subsection (f)
14-19 to read as follows:
14-20 (f) The board shall provide to its members, as often as
14-21 necessary, information regarding their qualifications for office or
14-22 employment under this Act and their responsibilities under
14-23 applicable laws relating to standards of conduct for state officers
14-24 or employees.
14-25 SECTION 4. Subsection (c), Section 14, Texas Pharmacy Act
15-1 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
15-2 read as follows:
15-3 (c) Except as otherwise provided by this subsection, all
15-4 board meetings and hearings shall be open to the public. The board
15-5 may, in its discretion and in accordance with the open meetings
15-6 law, Chapter 551, Government Code, [Chapter 271, Acts of the 60th
15-7 Legislature, Regular Session, 1967, as amended (Article 6252-17,
15-8 Vernon's Texas Civil Statutes),] conduct any portion of its meeting
15-9 in executive session. The board may in its discretion conduct
15-10 deliberations relative to licensee disciplinary actions in
15-11 executive session. At the conclusion of its deliberations relative
15-12 to licensee disciplinary action, the board shall vote and announce
15-13 its decision relative to the licensee in open session. The board
15-14 in executive session may conduct disciplinary hearings relating to
15-15 a pharmacist or pharmacy student who is impaired because of
15-16 chemical abuse or mental or physical illness.
15-17 SECTION 5. Subsections (c), (d), and (f), Section 15, Texas
15-18 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
15-19 amended to read as follows:
15-20 (c) An officer, employee, or paid consultant of a Texas
15-21 trade association in the field of health care may not be an [a
15-22 member or] employee of the board who is exempt from the state's
15-23 position classification plan or is compensated at or above the
15-24 amount prescribed by the General Appropriations Act for step 1,
15-25 salary group 17, of the position classification salary schedule.
16-1 (d) A person who is the spouse of an officer, manager, or
16-2 paid consultant of a Texas trade association in the field of health
16-3 care may not be a [board member and may not be a] board employee
16-4 who is exempt from the state's position classification plan or is
16-5 compensated at or above the amount prescribed by the General
16-6 Appropriations Act for step 1, salary group 17, of the position
16-7 classification salary schedule.
16-8 (f) The board shall provide to its [members and] employees,
16-9 as often as necessary, information regarding their qualification
16-10 for office or employment under this Act and their responsibilities
16-11 under applicable laws relating to standards of conduct for state
16-12 officers or employees.
16-13 SECTION 6. Subsections (o) and (q), Section 17, Texas
16-14 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
16-15 amended to read as follows:
16-16 (o) The board:
16-17 (1) shall [may] establish rules for the use of
16-18 pharmacy technicians [supportive personnel] and the duties of those
16-19 technicians [personnel] in pharmacies licensed by the board,
16-20 provided that those technicians [personnel] are responsible to and
16-21 directly supervised by a pharmacist licensed by the board; provided
16-22 however that the board may not adopt rules or regulations
16-23 establishing ratios of pharmacists to pharmacy technicians
16-24 [supportive personnel] in Class C pharmacies; and
16-25 (2) may determine and issue standards for recognition
17-1 and approval of training programs for pharmacy technicians and
17-2 maintain a list of training programs that meet the standards.
17-3 (q) Board investigative files and all information and
17-4 materials compiled by the board in connection with an investigation
17-5 are confidential and are not subject to disclosure under Chapter
17-6 552, Government Code [424, Acts of the 63rd Legislature, Regular
17-7 Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil
17-8 Statutes)], and are not subject to disclosure, discovery, subpoena,
17-9 or other means of legal compulsion for their release to anyone
17-10 other than the board or its employees or agents involved in
17-11 licensee discipline except that this information may be disclosed
17-12 to:
17-13 (1) persons involved with the board in a disciplinary
17-14 action against the licensee;
17-15 (2) pharmacist or pharmacy licensing or disciplinary
17-16 authorities of other jurisdictions;
17-17 (3) a pharmaceutical peer review committee as outlined
17-18 in Section 27A of this Act;
17-19 (4) law enforcement agencies; and
17-20 (5) persons engaged in bona fide research, if all
17-21 individual-identifying information has been deleted.
17-22 SECTION 7. Subsection (a), Section 17D, Texas Pharmacy Act
17-23 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
17-24 read as follows:
17-25 (a) The board by rule shall adopt procedures governing:
18-1 (1) informal disposition of a contested case under
18-2 Chapter 2001, Government Code [Section 13(e), Administrative
18-3 Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas
18-4 Civil Statutes), and its subsequent amendments]; and
18-5 (2) informal proceedings held in compliance with
18-6 Chapter 2001, Government Code [Section 18(c), Administrative
18-7 Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas
18-8 Civil Statutes), and its subsequent amendments].
18-9 SECTION 8. Subsections (a), (f), and (g), Section 19, Texas
18-10 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
18-11 amended to read as follows:
18-12 (a) A person may not:
18-13 (1) dispense or distribute prescription drugs unless
18-14 he is a licensed pharmacist or is authorized by this Act to
18-15 dispense or distribute prescription drugs; or
18-16 (2) operate a pharmacy unless he first obtains a
18-17 license to operate a pharmacy.
18-18 (f) This Act does not apply to:
18-19 (1) a member of the faculty of a college of pharmacy
18-20 that is recognized by the board if the faculty member is a licensed
18-21 pharmacist and performs his services for the benefit of the college
18-22 only;
18-23 (2) [a pharmacist-intern;]
18-24 [(3)] a person who procures prescription drugs for
18-25 lawful research, teaching, or testing and not for resale; or
19-1 (3) [(4)] a home and community support services agency
19-2 that possesses a dangerous drug as authorized by Section 142.0061,
19-3 Health and Safety Code.
19-4 (g) Any person found by the board to have unlawfully engaged
19-5 in the practice of pharmacy or unlawfully operated a pharmacy is
19-6 subject to a civil penalty under Section 37A of this Act [fine to
19-7 be imposed by the board not to exceed $1,000 for each offense].
19-8 Each violation of this Act or the rules adopted under this Act
19-9 pertaining to unlawfully engaging in the practice of pharmacy or
19-10 unlawfully operating a pharmacy also constitutes a Class A
19-11 misdemeanor.
19-12 SECTION 9. Section 20, Texas Pharmacy Act (Article 4542a-1,
19-13 Vernon's Texas Civil Statutes), is amended to read as follows:
19-14 Sec. 20. PHARMACIST-INTERN REGISTRATION. (a) A person
19-15 must register with the board before beginning the board-approved
19-16 internship in this state. An application for the registration of a
19-17 pharmacist-intern must be on a form prescribed by the board.
19-18 Registration shall remain in effect as long as the person meets the
19-19 qualifications for internship as specified by rules adopted by the
19-20 board [during internship training and thereafter until the earlier
19-21 of the following occurs:]
19-22 [(1) the failure of the pharmacist-intern to take the
19-23 next regularly scheduled examination; or]
19-24 [(2) the failure to pass the next regularly scheduled
19-25 examination].
20-1 (b) The board may in its discretion refuse to issue a
20-2 registration to an applicant and may restrict, suspend, or revoke a
20-3 pharmacist-intern registration for any violation of this Act. In
20-4 enforcing Section 26(a)(4) of this Act, the board shall, on
20-5 probable cause, request a pharmacist-intern or pharmacist-intern
20-6 applicant to submit to a mental or physical examination by
20-7 physicians or other health care professionals designated by the
20-8 board. If the pharmacist-intern or applicant refuses to submit to
20-9 the examination, the board shall issue an order requiring the
20-10 pharmacist-intern or applicant to show cause why he will not submit
20-11 to the examination and shall schedule a hearing on the order within
20-12 30 days after notice is served on the pharmacist-intern or
20-13 applicant. The board shall notify the pharmacist-intern or
20-14 applicant by either personal service or certified mail with return
20-15 receipt requested. At the hearing, the pharmacist-intern or
20-16 applicant and an attorney are entitled to present any testimony and
20-17 other evidence to show why the pharmacist-intern or applicant
20-18 should not be required to submit to the examination. After the
20-19 hearing, the board shall issue an order either requiring the
20-20 pharmacist-intern or applicant to submit to the examination or
20-21 withdrawing the request for examination.
20-22 SECTION 10. Subsections (a) and (e), Section 21, Texas
20-23 Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are
20-24 amended to read as follows:
20-25 (a) To qualify for a license to practice pharmacy, an
21-1 applicant for licensing by examination must submit to the board a
21-2 license fee as determined by the board and a completed application
21-3 on a form prescribed by the board with satisfactory sworn evidence
21-4 that he:
21-5 (1) is at least 18 years old;
21-6 (2) is of good moral character;
21-7 (3) has completed a minimum of a 1,000-hour internship
21-8 or other program that has been approved by the board or has
21-9 demonstrated, to the board's satisfaction, experience in the
21-10 practice of pharmacy that meets or exceeds the minimum internship
21-11 requirements of the board;
21-12 (4) has graduated and received a [the first
21-13 professional undergraduate degree or the advanced] professional
21-14 practice degree, as defined by the rules adopted by the board, from
21-15 an accredited pharmacy degree program approved by the board;
21-16 (5) has passed the examination required by the board;
21-17 and
21-18 (6) has not had a pharmacist license granted by
21-19 another state suspended, revoked, canceled, surrendered, or
21-20 otherwise restricted for any reason.
21-21 (e) The [Within 30 days after the date a licensing
21-22 examination is administered under this Act, the] board shall notify
21-23 each examinee of the results of the examination[. However, if an
21-24 examination is graded or reviewed by a national testing service,
21-25 the board shall notify each examinee of the results of the
22-1 examination] within 30 days [two weeks] after the date the board
22-2 receives the results from a national [the] testing service. [If
22-3 the notice of the examination results will be delayed for more than
22-4 90 days after the examination date, the board shall notify the
22-5 examinee of the reason for the delay before the 90th day.]
22-6 SECTION 11. Subsection (a), Section 22, Texas Pharmacy Act
22-7 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
22-8 read as follows:
22-9 (a) To qualify for a license to practice pharmacy by
22-10 reciprocity, an applicant for licensing must:
22-11 (1) submit to the board a reciprocity fee as
22-12 determined by the board and a completed application given under
22-13 oath, in the form prescribed by the board;
22-14 (2) have good moral character;
22-15 (3) have graduated and received a [the first
22-16 professional undergraduate degree or the advanced] professional
22-17 practice degree, as defined by the rules adopted by the board, from
22-18 an accredited pharmacy degree program approved by the board;
22-19 (4) have possessed at the time of initial licensing as
22-20 a pharmacist other qualifications necessary to have been eligible
22-21 for licensing at that time in this state;
22-22 (5) have presented to the board proof of initial
22-23 licensing by examination and proof that the license and other
22-24 license or licenses granted to the applicant by any other state
22-25 have not been suspended, revoked, canceled, surrendered, or
23-1 otherwise restricted for any reason; and
23-2 (6) pass the Texas [Drug and] Pharmacy Jurisprudence
23-3 examination.
23-4 SECTION 12. Subsection (b), Section 26, Texas Pharmacy Act
23-5 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
23-6 read as follows:
23-7 (b) Grounds for Disciplining a Holder of a Pharmacy License:
23-8 The board shall refuse to issue a pharmacy license for failure to
23-9 meet the requirements of Section 29 or 30 of this Act. The board
23-10 may in its discretion refuse to issue or renew a license or may
23-11 assess a penalty, reprimand, revoke, restrict, cancel, or suspend
23-12 any license granted by the board, and may probate any license
23-13 suspension if the board finds that the applicant or licensee has:
23-14 (1) been convicted of a felony or a misdemeanor
23-15 involving moral turpitude, or if the applicant or licensee is a
23-16 legal entity such as an association, joint stock company,
23-17 partnership, or corporation, that a managing officer has been
23-18 convicted of a felony or a misdemeanor involving moral turpitude
23-19 under the law of this state, another state, or the United States;
23-20 (2) advertised any prescription drugs or devices in a
23-21 deceitful, misleading, or fraudulent manner;
23-22 (3) violated any provision of this Act or any rule
23-23 adopted under this Act or that any owner or employee of a pharmacy
23-24 has violated any provision of this Act or any rule adopted under
23-25 this Act;
24-1 (4) sold without legal authorization prescription
24-2 drugs or devices to persons other than:
24-3 (A) a pharmacy licensed by the board;
24-4 (B) a practitioner;
24-5 (C) a person who procures prescription drugs or
24-6 devices for the purpose of lawful research, teaching, or testing,
24-7 and not for resale;
24-8 (D) a manufacturer or wholesaler registered with
24-9 the commissioner of health as required by Chapter 431, Health and
24-10 Safety Code; or
24-11 (E) a carrier or warehouseman;
24-12 (5) allowed an employee who is not a licensed
24-13 pharmacist to practice pharmacy;
24-14 (6) sold adulterated or misbranded prescription or
24-15 nonprescription drugs;
24-16 (7) failed to engage in or ceased to engage in the
24-17 business described in the application for a license;
24-18 (8) failed to keep and maintain records as required by
24-19 this Act, the Controlled Substances Act, Dangerous Drug Act, or
24-20 rules adopted under this Act or the Dangerous Drug Act; [or]
24-21 (9) failed to establish and maintain effective
24-22 controls against diversion of prescription drugs into other than
24-23 legitimate medical, scientific, or industrial channels as provided
24-24 by this Act or other state or federal laws or rules; or
24-25 (10) engaged in any fraud, deceit, or
25-1 misrepresentation as defined by the rules adopted by the board in
25-2 operating a pharmacy or in seeking a license to operate a pharmacy.
25-3 SECTION 13. Subsection (c), Section 26A, Texas Pharmacy Act
25-4 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
25-5 read as follows:
25-6 (c) Any disciplinary action taken by the board under this
25-7 section is governed by the Administrative Procedure Act (Chapter
25-8 2001, Government Code [and Texas Register Act (Article 6252-13a,
25-9 Vernon's Texas Civil Statutes]) and the rules of practice and
25-10 procedure adopted by the board.
25-11 SECTION 14. Section 27, Texas Pharmacy Act (Article 4542a-1,
25-12 Vernon's Texas Civil Statutes), is amended to read as follows:
25-13 Sec. 27. PROCEDURE. Except as provided in Section 27A of
25-14 this Act, any disciplinary action taken by the board under Section
25-15 26, 26A, or 26B of this Act is governed by the Administrative
25-16 Procedure Act (Chapter 2001, Government Code [and Texas Register
25-17 Act (Article 6252-13a, Vernon's Texas Civil Statutes]) and the
25-18 rules of practice and procedure before the board.
25-19 SECTION 15. Subsection (d), Section 27A, Texas Pharmacy Act
25-20 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
25-21 read as follows:
25-22 (d) The records and proceedings of the board, its authorized
25-23 agents, or any pharmaceutical organization committee as set out in
25-24 Subsections (a) and (b) of this section shall be confidential and
25-25 are not considered open records for the purposes of Chapter 552,
26-1 Government Code [424, Acts of the 63rd Legislature, Regular
26-2 Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil
26-3 Statutes)]; provided, however, the board may disclose this
26-4 confidential information only:
26-5 (1) in a disciplinary hearing before the board or in a
26-6 subsequent trial or appeal of a board action or order;
26-7 (2) to the pharmacist licensing or disciplinary
26-8 authorities of other jurisdictions;
26-9 (3) pursuant to an order of a court of competent
26-10 jurisdiction; or
26-11 (4) pursuant to Subsection (j) of this section.
26-12 SECTION 16. Subsection (c), Section 27B, Texas Pharmacy Act
26-13 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
26-14 read as follows:
26-15 (c) The identity of a person who reports to or assists the
26-16 board under this section and any document that could disclose the
26-17 identity of that person is confidential and does not constitute
26-18 public information for the purposes of Chapter 552, Government Code
26-19 [424, Acts of the 63rd Legislature, Regular Session, 1973 (Article
26-20 6252-17a, Vernon's Texas Civil Statutes)].
26-21 SECTION 17. Subsection (a), Section 28, Texas Pharmacy Act
26-22 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
26-23 read as follows:
26-24 (a) On the finding of the existence of grounds for
26-25 discipline of any person holding a license or seeking a license or
27-1 a renewal license under this Act, the board may impose one or more
27-2 of the following penalties:
27-3 (1) suspension of the offender's license;
27-4 (2) revocation of the offender's license;
27-5 (3) restriction of the offender's license to prohibit
27-6 the offender from performing certain acts or from engaging in the
27-7 practice of pharmacy or operating a pharmacy in a particular manner
27-8 for a term and under conditions to be determined by the board;
27-9 (4) imposition of an administrative penalty under
27-10 Section 28B of this Act;
27-11 (5) refusal to issue or renew the offender's license;
27-12 (6) placement of the offender's license on probation
27-13 and supervision by the board for a period to be determined by the
27-14 board and imposition of a requirement that the licensee:
27-15 (A) report regularly to the board on matters
27-16 that are the basis of the probation;
27-17 (B) limit practice to the areas prescribed by
27-18 the board; [or]
27-19 (C) continue or review professional education
27-20 until the licensee attains a degree of skill satisfactory to the
27-21 board in those areas that are the basis of the probation; or
27-22 (D) pay the board a probation fee to defray the
27-23 costs of monitoring a licensee during the period of probation;
27-24 (7) reprimand;
27-25 (8) cancellation of the offender's license; or
28-1 (9) retirement of the offender's license as provided
28-2 by board rule[; or]
28-3 [(10) imposition of a civil penalty that does not
28-4 exceed $1,000 for each day of each violation and that may be
28-5 collected in a suit initiated by the board].
28-6 SECTION 18. Subsection (e), Section 29, Texas Pharmacy Act
28-7 (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to
28-8 read as follows:
28-9 (e) The board shall have the discretion to determine under
28-10 which classifications a pharmacy applicant may be licensed. With
28-11 respect to Class C pharmacies, the board may establish rules for
28-12 the use of pharmacy technicians [supportive personnel] and the
28-13 duties of those technicians [personnel] in Class C pharmacies
28-14 licensed by the board, provided that these technicians [personnel]
28-15 are responsible to and directly supervised by a pharmacist licensed
28-16 by the board; provided, however, the board may not adopt any rule
28-17 setting ratios with respect to pharmacists and pharmacy technicians
28-18 [supportive personnel] or limiting the number of pharmacy
28-19 technicians [supportive personnel] that may be utilized.
28-20 SECTION 19. Section 35, Texas Pharmacy Act (Article 4542a-1,
28-21 Vernon's Texas Civil Statutes), is amended to read as follows:
28-22 Sec. 35. UNLAWFUL USE OF "PHARMACY." (a) A person may
28-23 not display in or on any store or place of business the word
28-24 "pharmacy," either in English or any other language, any other word
28-25 or combination of words of the same or similar meaning, or any
29-1 graphic representation that would mislead or tend to mislead the
29-2 public unless it is a pharmacy licensed under this Act.
29-3 (b) A person may not advertise any store or place of
29-4 business as a pharmacy or provide pharmacy services unless the
29-5 facility is a pharmacy licensed under this Act.
29-6 SECTION 20. The Texas Pharmacy Act (Article 4542a-1,
29-7 Vernon's Texas Civil Statutes) is amended by adding Section 37A to
29-8 read as follows:
29-9 Sec. 37A. CIVIL PENALTY. (a) A person who violates the
29-10 license requirements of this Act is liable to the state for a civil
29-11 penalty of up to $1,000 for each day the violation continues.
29-12 (b) At the request of the board, the attorney general shall
29-13 institute an action to collect a civil penalty from a person who
29-14 has violated this Act or rules adopted under this Act.
29-15 (c) If the attorney general fails to take action within 30
29-16 days of referral from the board, the board shall refer the case to
29-17 the local district attorney, county attorney, or city attorney.
29-18 The district attorney, county attorney, or city attorney shall file
29-19 suit in a district court to collect and retain the penalty.
29-20 (d) Venue for a suit under this section is in Travis County.
29-21 SECTION 21. Section 40, Texas Pharmacy Act (Article 4542a-1,
29-22 Vernon's Texas Civil Statutes), is amended by adding Subsection (m)
29-23 to read as follows:
29-24 (m) Except as provided by this subsection, drug product
29-25 selection authorized in this section does not apply to the refill
30-1 of a prescription for a narrow therapeutic index drug. The board,
30-2 in consultation with the Texas State Board of Medical Examiners,
30-3 shall establish, by rule, a list of narrow therapeutic index drugs
30-4 that are subject to this subsection. A prescription for a narrow
30-5 therapeutic index drug may be refilled only by using the same drug
30-6 product by the same manufacturer that the pharmacist last dispensed
30-7 under the prescription, unless otherwise agreed to by the
30-8 prescribing physician. If a pharmacist does not have the same drug
30-9 product by the same manufacturer in stock to refill the
30-10 prescription, the pharmacist may dispense a drug product that is
30-11 generically equivalent if the pharmacist, before dispensing the
30-12 generically equivalent drug product, notifies:
30-13 (1) the patient, at the time the prescription is
30-14 dispensed, that a substitution of the prescribed drug product has
30-15 been made; and
30-16 (2) the prescribing practitioner of the drug product
30-17 substitution by telephone, facsimile, or mail, at the earliest
30-18 reasonable time, but not later than 72 hours after dispensing the
30-19 prescription.
30-20 SECTION 22. Subdivisions (10) and (11), Section 483.001,
30-21 Health and Safety Code, are amended to read as follows:
30-22 (10) "Pharmacy" means a facility where prescription
30-23 drug or medication orders are received, processed, dispensed, or
30-24 distributed under this chapter, Chapter 481, and the Texas Pharmacy
30-25 Act (Article 4542a-1, Vernon's Texas Civil Statutes). The term
31-1 does not include a narcotic drug treatment program that is
31-2 regulated by Chapter 466, Health and Safety Code [licensed by the
31-3 board pursuant to Section 29, Texas Pharmacy Act (Article 4542a-1,
31-4 Vernon's Texas Civil Statutes)].
31-5 (11) "Practice of pharmacy" means:
31-6 (A) provision of those acts or services
31-7 necessary to provide pharmaceutical care;
31-8 (B) interpretation and evaluation of
31-9 prescription drug orders or medication orders;
31-10 (C) participation in drug and device selection
31-11 as authorized by law, drug administration, drug regimen review, or
31-12 drug or drug-related research;
31-13 (D) provision of patient counseling; [and]
31-14 (E) responsibility for:
31-15 (i) dispensing of prescription drug orders
31-16 or distribution of medication orders in the patient's best
31-17 interest;
31-18 (ii) compounding and labeling of drugs and
31-19 devices, except labeling by a manufacturer, repackager, or
31-20 distributor of nonprescription drugs and commercially packaged
31-21 prescription drugs and devices;
31-22 (iii) proper and safe storage of drugs and
31-23 devices; or [and]
31-24 (iv) maintenance of proper records for
31-25 drugs and devices. In this subdivision, "device" has the meaning
32-1 assigned by the Texas Pharmacy Act (Article 4542a-1, Vernon's Texas
32-2 Civil Statutes); or
32-3 (F) performance of a specific act of drug
32-4 therapy management for a patient delegated to a pharmacist by a
32-5 written protocol from a physician licensed by the state under the
32-6 Medical Practice Act (Article 4495b, Vernon's Texas Civil
32-7 Statutes).
32-8 SECTION 23. Subsection (b), Section 483.003, Health and
32-9 Safety Code, is amended to read as follows:
32-10 (b) On making that finding, the Texas Board of Health
32-11 [board] may limit the availability of the abused drug by permitting
32-12 its dispensing only on the prescription of a practitioner described
32-13 by Section 483.001(12)(A) or (B).
32-14 SECTION 24. Subsection (e), Section 483.042, Health and
32-15 Safety Code, is amended to read as follows:
32-16 (e) The labeling provisions of Subsection (a) do not apply
32-17 to a dangerous drug prescribed or dispensed for administration to a
32-18 patient who is institutionalized. The board shall adopt rules for
32-19 the labeling of such a drug [food production animals in an
32-20 agricultural operation under a written medical directive or
32-21 treatment guideline from a veterinarian licensed under The
32-22 Veterinary Licensing Act (Article 8890, Revised Statutes) and its
32-23 subsequent amendments].
32-24 SECTION 25. Chapter 107, Acts of the 41st Legislature,
32-25 Regular Session, 1929 (Article 4542a, Vernon's Texas Civil
33-1 Statutes), is repealed.
33-2 SECTION 26. Subsection (b), Section 26A, Texas Pharmacy Act
33-3 (Article 4542a-1, Vernon's Texas Civil Statutes), as amended by
33-4 Section 7, Chapter 789, Acts of the 73rd Legislature, 1993, is
33-5 repealed.
33-6 SECTION 27. This Act takes effect September 1, 1997.
33-7 SECTION 28. (a) This Act applies only to a license issued
33-8 or renewed by the Texas State Board of Pharmacy on or after the
33-9 effective date of this Act. A license issued or renewed before
33-10 that date is governed by the law in effect on the date the license
33-11 was issued or renewed, and the former law is continued in effect
33-12 for that purpose.
33-13 (b) Section 37A, Texas Pharmacy Act (Article 4542a-1,
33-14 Vernon's Texas Civil Statutes), as added by this Act, applies only
33-15 to a violation of the licensing requirements of the Texas Pharmacy
33-16 Act (Article 4542a-1, Vernon's Texas Civil Statutes) that occurs on
33-17 or after the effective date of this Act.
33-18 SECTION 29. The importance of this legislation and the
33-19 crowded condition of the calendars in both houses create an
33-20 emergency and an imperative public necessity that the
33-21 constitutional rule requiring bills to be read on three several
33-22 days in each house be suspended, and this rule is hereby suspended.
_______________________________ _______________________________
President of the Senate Speaker of the House
I hereby certify that S.B. No. 609 passed the Senate on
April 9, 1997, by a viva-voce vote; and that the Senate concurred
in House amendments on May 29, 1997, by a viva-voce vote.
_______________________________
Secretary of the Senate
I hereby certify that S.B. No. 609 passed the House, with
amendments, on May 27, 1997, by a non-record vote.
_______________________________
Chief Clerk of the House
Approved:
_______________________________
Date
_______________________________
Governor